The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.
Study Type
OBSERVATIONAL
Enrollment
25
The Alfred Hospital
Melbourne, Victoria, Australia
AKH Medical University of Vienna
Vienna, Austria
Toronto General Hospital
Toronto, Ontario, Canada
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
Survival
Subject outcomes and survival over time
Time frame: At 5 years post HM3 CE Mark study implant
EuroQoL 5D-5L (EQ-5D-5L) VAS Score
Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life
Time frame: At 5 years post HM3 CE Mark study implant
Six Minute Walk Test (6MWT)
Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes
Time frame: At 5 years post HM3 CE Mark study implant
New York Heart Association (NYHA)
Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: At 5 years post HM3 CE Mark study implant
Adverse Events
Number of Participants with Adverse Events
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
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Deutsches Herzzentrum Berlin
Berlin, Germany
Universitats-Herzzentrum Freiburg
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Hanover, Germany
National Research Center for Cardiac Surgery
Astana, Kazakhstan
Device Malfunctions
Number of Participants with device malfunctions
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Reoperations
Number of reoperations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Rehospitalizations
Number of rehospitalizations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
Modified Rankin Score \>3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead
Time frame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first